Unflavored Powdered Multivitamin in Children
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-11
SponsorEllaOla
About this trial
The goal of this clinical trial is to learn whether a daily unflavored powdered multivitamin (EllaOla Kids Essentials) improves mood and behavior in children aged 4 to 11 who are picky eaters and experience behavioral challenges. Researchers will also look at whether the multivitamin affects overall health, well-being, nutrition, and serum vitamin levels, and whether it is safe and well tolerated.
The main questions it aims to answer are:
Do more parents of children taking the multivitamin report a clinically meaningful improvement in their child's overall mood and behavior after 12 weeks than parents of children taking a placebo? Does the multivitamin change parent-reported emotional reactivity, overall health and well-being, and nutrition over 12 weeks? In children who take part in optional at-home blood testing, does the multivitamin improve serum vitamin D and vitamin B12 levels?
Researchers will compare the multivitamin to a placebo (a look-alike powder made of tapioca fiber that contains no vitamins) to see if it improves mood and behavior.
Participants will:
Be randomly assigned to receive either the multivitamin or the placebo. Neither the families nor the study team will know which one the child gets.
Have a parent or caregiver mix the powder into the child's food or drink once a day at home for 12 weeks.
Have a parent or caregiver complete short online questionnaires about the child's mood, behavior, health, and nutrition at baseline and at Weeks 2, 4, 6, 8, and 12, using a smartphone app. All study visits are remote.
Choose whether to do an optional at-home blood collection at the start and at Week 12.
Choose whether to continue in an optional 12-week open-label extension (Weeks 12-24), where all children, including those who were on placebo, receive the multivitamin.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Healthy child aged 4-11 years at time of enrollment, male or female
Not currently taking oral over-the-counter supplements or another multivitamin, if they are taking, must discontinue use for at least four weeks prior to randomization and for the duration of the study.
Parent reports active concern/challenge in behavior and selective eating confirmed by minimum threshold scores on three screening instruments: a. Selective Eating: </= 3 on the Selective Eating Screening Tool Section A and at least two behavioral anchors Q11 = concern about child's nutrition "3-4 days per week or 5-7 days per week), Q12 = "fewer than 20 foods" (10-19 or fewer than 10), Q13 = refusal of ≥ 1 whole food group b. Behavior: Participants must meet both of the following criteria: 1. EDI Reactivity T-score ≥ 60 (for EDI or EDI-YC dependent on age of child); indicating elevated emotional reactivity relative to age-based norms (general population norms); -AND- 2. Behavioral Screening Tool: Evidence of clinically meaningful baseline difficulty in behavior and emotional regulation, defined as: ○ A rating of "Often" or "Very Often" (score ≥ 4) on all three Mood and Behavior Difficulties screening items;
Generally healthy as determined by caregiver report without any chronic medical condition that is unstable is actively being treated with medication changes, or that in the judgment of the Investigator would interfere with study participation or interpretation of results.
Disqualifiers
Parent does not have a personal smartphone, internet access, or is unwilling to download Chloe.
Child does not meet minimum threshold screening scores in two domains as specified in Inclusion Criteria 3
Current use of stimulant medication, antipsychotics, or appetite-modifying medications that has been initiated or changed within 8 weeks prior to enrollment (stable, long-term use may be considered on a case-by-case basis with Investigator approval).
Current use of any medication, supplement, or herbal remedy specifically targeted at behavior or appetite that has been initiated or changed within 8 weeks prior to randomization, or that the caregiver is unwilling to keep stable and unchanged for the duration of the study
Trial design
Design model
Parallel
Treatments tested in this trial
EllaOla Kids Essentials Unflavored Powdered Multivitamin
Dietary supplementAn unflavored, powdered children's multivitamin. Each serving provides vitamins A, C, D3 (20 mcg), E, K2, B1, B3, B5, B6, B12 (2 mcg), folate, and biotin, plus iodine, zinc, selenium, manganese, and a fruit and vegetable blend, in a tapioca fiber base with monk fruit. Parents/caregivers give one full serving once daily in the morning, mixed into at least 2 ounces of juice or milk, for 12 weeks. Participants who opt into the open-label extension continue daily use through Week 24.
Placebo (Tapioca Fiber)
Dietary supplementA tapioca fiber powder with no vitamins or minerals, matched to the study product in appearance, packaging, and labeling. Parents/caregivers give one full serving once daily in the morning, mixed into at least 2 ounces of juice or milk, for the 12-week double-blind period. Used as Placebo comparator only.
Treatment groups
166 Participants
are divided into 2 treatment groupsGroup A: Arm 1 - Experimental: EllaOla Kids Essentials MultivitaminExperimental treatment 1 intervention
Group B: Arm 2 - Placebo Comparator: Placebo (Tapioca Fiber)Placebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Proportion of PGI-C Responders on the Overall Mood and Behavior Item
Proportion of participants rated by their parent/caregiver as "very much improved" (1) or "much improved" (2) on the Overall Mood and Behavior item of the Parent Global Impression of Change (PGI-C). The PGI-C is rated on a 7-point scale (1 = very much improved; 4 = no change; 7 = very much worse). Lower scores indicate greater improvement.
Time frame
Week 12Secondary outcomes
1
Proportion of PGI-C Responders on the Overall Mood and Behavior Item Over Time
Proportion of participants rated "very much improved" (1) or "much improved" (2) on the PGI-C Overall Mood and Behavior item. The 7-point scale runs from 1 = very much improved to 7 = very much worse, with 4 = no change.
Time frame
Weeks 2, 4, 6, 8, and 122
Proportion of PGI-C Improvers on the Overall Mood and Behavior Item
Proportion of participants rated "very much improved" (1), "much improved" (2), or "minimally improved" (3) on the PGI-C Overall Mood and Behavior item. The 7-point scale runs from 1 = very much improved to 7 = very much worse, with 4 = no change.
Time frame
Weeks 2, 4, 6, 8, and 123
Mean PGI-C Overall Mood and Behavior Score
Mean parent-rated score on the PGI-C Overall Mood and Behavior item. The 7-point scale runs from 1 = very much improved to 7 = very much worse, with 4 = no change. Lower scores indicate greater improvement.
Time frame
Weeks 2, 4, 6, 8, and 124
Change From Baseline in Serum 25-Hydroxyvitamin D [25(OH)D] (Blood Work Subgroup)
Change from baseline in serum 25(OH)D in the optional blood work subgroup. Samples are collected at home with the Tasso Mini device.
Time frame
Baseline and Week 12Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
EllaOla
Lead sponsor
People Science, Inc.
Collaborator
Source ClinicalTrials.gov
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